Cleaner Long-tErm Assessment Registry - Venous Insights and Efficacy With eXtended Tracking

Exclusion Criteria

• •Subjects will be excluded from the study if any of the following criteria are met:
• •1. Contraindication to systemic or therapeutic doses of anticoagulants.
• •2. Contraindication to iodinated contrast that cannot be adequately premedicated.
• •3. Life expectancy less than 1 year due to advanced malignancy, as determined by the investigator at the time of enrollment
• •4. Patients that are pregnant.
• •5. Known coagulation disorders both acquired (Heparin Induced Thrombocytopenia, etc.) or genetic (e.g., Factor V Leiden, etc.), thrombophilia, or hypercoagulable states that, in the opinion of the Investigator, cannot be medically managed throughout the study period.
• •6. Treatment of target venous segment with thrombolytics within previous 14 days of the index procedure.
• •7. Known congenital anatomic anomalies of the inferior vena cava (IVC) or iliac veins.
• •8. Known history of a Patent Foramen Ovale (PFO).
• •9. Hemoglobin \< 8.0 g/dL, INR \> 2.0 before warfarin was started, or platelets \< 50,000/µl which cannot be corrected prior to enrollment.
• •10. Severe renal impairment (estimated GFR \< 30 ml/min) in patients who are not yet on dialysis. Patients with GFR \<30 ml/min who are already on dialysis can be enrolled.
• •11. Patients with intermediate-high risk or high-risk pulmonary embolism (PE) defined as follows:
• •1. High-risk PE: Presence of hemodynamic instability, including cardiac arrest, obstructive shock (systolic blood pressure \<90 mmHg or need for vasopressors with signs of end-organ hypoperfusion), or persistent hypotension (systolic BP \<90 mmHg or a drop ≥40 mmHg for \>15 minutes not due to other causes)
• •2. Intermediate-high-risk PE: Hemodynamically stable patients with both right ventricular (RV) dysfunction (on echocardiography or CT) and elevated cardiac biomarkers (e.g., troponin).
• •12. Complete infrarenal IVC occlusion.
• •13. Chronic non-ambulatory status.
• •14. Current enrollment in another investigational device or drug study that may confound the results of this study. Studies requiring extended follow-up for products that were investigational but have since become commercially available are not considered investigational studies.